Less than a year after garnering the first anti-CLDN18.2 approval in the U.S., Astellas Pharma is not resting on its laurels. The Japanese pharma giant is doubling down on the star solid tumor target with a new licensing deal for a phase 2 antibody-drug conjugate worth up to $1.34 billion.
The CLDN18.2-targeting ADC comes from Chinese biotech Evopoint Biosciences. Astellas will pay Evopoint an upfront fee of $130 million, with potential near-term milestones worth $70 million, the companies announced in a May 29 release.
Adding in additional payments from development, regulatory and commercialization milestones leads to the $1.34 billion total, which Evopoint can grow even further if the asset is approved with royalties on future net sales.
In return, Astellas will receive exclusive worldwide rights to develop and commercialize XNW27011, with the exception of China, Hong Kong, Macao and Taiwan, according to the release.
“XNW27011 is a promising new asset that complements Astellas’ pipeline and enhances our leading position in precision oncology," Astellas Chief Strategy Officer Adam Pearson said in the release. "We look forward to harnessing our expertise in targeting CLDN18.2 and specialized knowledge in GI cancers to advance XNW27011 and deliver meaningful outcomes to patients."
XNW27011 will join Astellas’ roster of CLDN-targeting therapies, including ADCs and drugs with other modalities, the company said in the release. Evopoint is currently testing the drug candidate in a phase 1/2 trial in patients with advanced or metastatic solid tumors, including gastric, pancreatic, colorectal, ovarian and other cancers.
CLDN18.2 (or Claudin 18.2) is a tight junction protein, forming part of the protein complex that binds epithelial cells together in the gastrointestinal system. CLDN18.2 is hidden under the surface of normal tissue but is often expressed on the outside of tumor cells, making it an attractive therapeutic target.
Biotechs and pharmas have endeavored to fight cancer by targeting CLDN18.2 for several years, but it was Astellas that nabbed the first approval in October 2024 with Vyloy (zolbetuximab), a first-line treatment for certain gastric tumors.
Others have been less successful. Elevation Oncology dropped its own CLDN18.2-targeting ADC for gastric cancer, the biotech’s sole clinical asset, in March after phase 1 data failed to show much efficacy.
AstraZeneca, Leap Therapeutics, Legend Biotech and Moderna are all pursuing the transmembrane protein target, while Merck & Co. recently backed out of the field by returning global rights to Kelun-Biotech’s CLDN18.2-directed ADC SKB315. To date, no other drugs targeting CLDN18.2 have been approved by the FDA.
Astellas and Evopoint’s deal comes on the eve of the annual American Society of Clinical Oncology (ASCO) conference in Chicago, where Astellas will give 16 presentations. At last year’s ASCO, Astellas Chief Medical Officer Tadaaki Taniguchi, M.D., Ph.D., said the company was pursuing "the ADC, hybrid approach, or thinking about bispecifics and target-based drug discovery,” which is part of a trend of companies abandoning costly cell therapies and radiopharmaceuticals in favor of tried-and-true oncology methods.